Postpartum Evaluation of Nifedipine and Enalapril for Hyp... | NCT07023003

Studies
Postpartum Evaluation of Nifedipine and Enalapril for Hypertension

NCT07023003

Sponsor

Nebraska Methodist Health System

Status

Recruiting

Last Update Posted

Oct 22, 2025Actual

Enrollment

850Estimated

Phase

Phase 4

Conditions

Hypertension in Pregnancy

Interventions

Enalapril 10mg QD
Nifedipine 30mg XL BID

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2025Actual

Primary Completion Date

Jul 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Jun 8, 2025

First Submission Date that Met QC Criteria

Jun 8, 2025

First Posted Date

Jun 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2025

Last Update Posted Date

Oct 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Todd Lovgren, Principal Investigator, Nebraska Methodist Health SystemPrincipal Investigator

Lead Sponsor

Nebraska Methodist Health SystemOTHER

Collaborators

Name	Class
Methodist Hospital Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open label, randomized controlled trial designed to compare nifedipine and enalapril in the management of postpartum hypertension. This is an equivalence study- meaning it is not expected one medication is better than the other. Nifedipine has been shown to be better than another common blood pressure medicine, labetalol, for postpartum hypertension but enalapril which is also used worldwide to manage blood pressure postpartum, has not yet been evaluated or compared to nifedipine.

Investigators will identify and offer enrollment to women who are admitted for delivery with documented hypertension- participants with either chronic hypertension or pregnancy related hypertension will be included. Our hypothesis is both medications are safe and effective in managing blood pressure and preventing readmission for hypertensive complications during the postpartum period so evaluating the rate of readmission is the primary goal of the study.

The only intervention of the trial will be to assign which medication the participant starts taking. Any decisions after that point- stopping medication, changing doses, additional medications, discharge from the hospital, etc, will all be at the discretion of the participant's primary provider.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

850Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nifedipine XR	Active Comparator	Patients will be randomized to receive nifedipine 30mg XR BID. Any additional changes in treatment will be at the discretion of their provider.	Drug: Nifedipine 30mg XL BID
Enalapril 10mg QD	Experimental	Patients will be administered 10mg enalapril daily. Any additional intervention or changes in management of their hypertension will be at the discretion of their primary provider.	Drug: Enalapril 10mg QD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enalapril 10mg QD	Drug	Enalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.	Enalapril 10mg QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital Readmission	Number of participants meeting criteria for hospital admission.	Within 6 weeks of delivery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

admitted for delivery by cesarean or vaginal delivery
24 weeks gestation or greater
Pregnancy related hypertension(HTN) or chronic hypertension. Pregnancy related hypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart. This definition is consistent with the ACOG definition for pregnancy related HTN in patients without CHTN.

Exclusion Criteria:

Absolute contraindication to either nifedipine or enalapril Relative contraindications will be reviewed with PI.
Persistent HR <60 or >110
Native language other than English

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Todd Lovgren, MD	Contact	14028151970		todd.lovgren@nmhs.org
Joshua Dahlke, MD	Contact	14028151970		joshua.dahlke@nmhs.org

Overall Officials

Name	Affiliation	Role
Todd Lovgren, MD	Nebraska Methodist Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Women's Hospital	Recruiting	Omaha	Nebraska	68022	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Requests for data sharing will be reviewed on a case by case basis.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

1 year after completion of the study and for up to 10 years after completion assuming continued access to data is available.

Access Criteria

Access will be provided on a case by case basis. If shared, an encrypted and deidentified spreadsheet with non-identifying data will be provided.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D006973	Hypertension

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004656	Enalapril
D015773	Enalaprilat
D009543	Nifedipine

Ancestor Terms

ID	Term
D004151	Dipeptides
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided